Models of Primary Osteoporosis Screening in Male Veterans

NCT04079868 | Completed Results DMC

• 1 other identifier: IIR 17-202
• Study Type: interventional
• Target: 3,512
• Locations: 1 country
• Sites: 3

Brief Summary

Models of Osteoporosis Screening in Male Veterans aims to test 1 distinct care model of primary osteoporosis screening in men within the VA healthcare setting. All care models deliver VA recommended osteoporosis screening and treatment to high-risk Veterans by appropriate Durham VA clinical staff. The MOPS project will evaluate patient, provider and facility outcomes to determine the effectiveness of each intervention.

Conditions

Osteoporosis; Osteopenia; Osteoporotic Fracture

Keywords

Osteoporosis; Osteopenia; Osteoporotic fracture; Age-Related Osteoporosis; Bone Loss, Age-Related

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants Screened for Osteoporosis

  Proportion of men who received DXA screening for for osteoporosis. Numerator is the number of men with a completed screening DXA, denominator is all patients meeting current osteoporosis screening criteria

  through study completion, an average of 1.5 years

• Bone Mineral Density T-score at the Femoral Neck

  Bone mineral density in gm/cm2 as measured by DXA, converted to T-score by the densitometer manufacturer. The T score reflects the number of standard deviations away from the mean bone density of young healthy women as defined in the National Health and Nutrition Survey. Lower T-scores reflect worse bone density, and T-scores \<= -1 are consistent with osteopenia or osteoporosis. This outcome was measured in a random subset of enrolled patients (target n=25 per primary care team), regardless of whether or not they had undergone osteoporosis screening during the study period.

  2 years after the primary care team's start date

Secondary Outcomes (5)

• Gastrointestinal Medication Prescriptions

  through study completion, an average of 1.5 years

• Osteoporosis Medication Adherence (Proportion of Days Covered)

  through study completion, an average of 1.5 years

• Proportion of Patients Initiating Osteoporosis Medication (%)

  through study completion, an average of 1.5 years

• Osteoporosis Medication Persistence (Days)

  through study completion, up to 2 years

• Proportion With Fractures

  through study completion, an average of 1.5 years

Study Arms (2)

Bone Health Service arm

EXPERIMENTAL

Interventional arm

Behavioral: Bone Health Service Model

Usual care (control) arm

NO INTERVENTION

This arm represents a "no practice management support" control group.

Interventions

Bone Health Service Model BEHAVIORAL

Patients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team.

Bone Health Service arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provider with at least 0.75 FTE
• Provider has completed training (i.e., PACT teams led by residents and fellows are excluded)
• Care for male Veterans \>65 years (i.e., Women's Health PACTs are excluded)
• No prior fracture or osteoporosis diagnosis
• At least 1 VA Undersecretary Guideline risk factor (weight loss \>20% in 5 years; BMI \<25 kg/m2; diabetes; pernicious anemia; gastrectomy; anticonvulsants; glucocorticoids; androgen deprivation therapy; hyperthyroidism; hyperparathyroidism; rheumatoid arthritis; alcohol dependence; chronic lung disease; chronic liver disease; stroke; Parkinsonism; prostate cancer; and current smoking).
• Men aged 65-85 years
• Enrolled in eligible PACT team for at least 2 years
• Meet 1 or more criteria for osteoporosis screening as the protocol at PACT enrollment.

You may not qualify if:

• None

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148-0001, United States

Location

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249-0001, United States

Location

Related Publications (1)

• Colon-Emeric C, Lee R, Lyles KW, Zullig LL, Sloane R, Pieper CF, Nelson RE, Adler RA. Remote Bone Health Service for Osteoporosis Screening in High-Risk Men: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2025 Oct 1;185(10):1218-1224. doi: 10.1001/jamainternmed.2025.4150.

  PMID: 40853653 DERIVED

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Osteoporotic Fractures

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fractures, Bone; Wounds and Injuries

Results Point of Contact

• Title: Dr. Cathleen Colon-Emeric
• Organization: Durham VA Geriatric Research Education and Clinical Center

cathleen.colon-emeric@va.gov

9192860411

Study Officials

• Cathleen S Colon-Emeric, MD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be masked to the group assignment
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Stratified, block randomization will be used. A statistician unaware of team identity will randomize PACTs in blocks of 2 within strata to ensure similar distributions. If insufficient numbers of PACTs are recruited within small CBOCs, they will be combined with other similar CBOCs (rural vs. urban) for randomization.

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 6, 2019
• Study Start: August 30, 2019
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 14, 2025
• Results First Posted: October 14, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)